Status:
UNKNOWN
Evaluation of the Brain Activity During Spinal Cord Stimulation in Failed Back Surgery Syndrome Using Functional MRI and MRS
Lead Sponsor:
Universitair Ziekenhuis Brussel
Collaborating Sponsors:
Maarten Moens
Conditions:
Failed Back Surgery Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Functional Magnetic Resonance Imaging (fMRI)and MR Spectroscopy of the brain are perfect tools to investigate the changes in the brainstem and brain evoked by the orthodromically impulses of a SCS.
Detailed Description
In case a patient meets all inclusion and no exclusion criteria, he/she will be implanted with an epidural neurostimulation lead (electrode). The day of implant will be recorded as day 0 (table 1) an...
Eligibility Criteria
Inclusion
- Age male/female patient ≥ 18 years
- Patient diagnosed with Failed Back Surgery Syndrome with at least one prior spinal surgery
- Patient with low back pain and/or pain in at least one leg
- Pain intensity at baseline assessed by VAS \> 5 (50%)
- Patient willing to provide informed consent.
Exclusion
- Use of spinal cord stimulation in this patient in the past.
- Presence of other clinically significant or disabling chronic pain condition
- Expected inability of patients to receive or properly operate the spinal cord stimulation system
- History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
- Active malignancy
- Current use of medication affecting coagulation which cannot be temporarily stopped
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- Life expectancy of less than 1 year
- Existing or planned pregnancy
- Existing extreme fear for entering MRI
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01181817
Start Date
September 1 2008
End Date
September 1 2011
Last Update
August 18 2010
Active Locations (1)
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1
UZ Brussel
Brussels, Brussels Capital, Belgium, 1090